Roma Drug and Rodriguez vs. RTC of Guagua, Pampanga

The passage of Republic Act No. 9502, which expressly allows private third parties to import patented drugs and medicines introduced anywhere in the world, implicitly repeals the conflicting provisions of Republic Act No. 8203 that classify such imported drugs as "counterfeit" and impose criminal penalties therefor; consequently, the prosecution of the petitioner under the superseded law is no longer warranted.

The case addresses the tension between intellectual property rights protection under the Special Law on Counterfeit Drugs and the constitutional mandate to ensure affordable access to essential medicines. Prior to the enactment of RA 9502, the importation of genuine but "unregistered" drugs—those not purchased from the local patent holder—was criminalized, creating barriers to affordable medicine for impoverished Filipinos and preventing parallel importation of cheaper pharmaceuticals legally available abroad.

• Petitioner Romeo Rodriguez is the proprietor of Roma Drug, a duly registered sole proprietorship operating a drugstore in San Matias, Guagua, Pampanga.
• On August 14, 2000, a composite team of NBI operatives and BFAD inspectors conducted a raid on Roma Drug pursuant to Search Warrant No. 00-43 issued by the RTC of Angeles City, Branch 57.
• The raiding team seized several imported medicines including Augmentin (375mg) tablets, Orbenin (500mg) capsules, Amoxil (250mg) capsules, and Ampiclox (500mg).
• The seized medicines were manufactured by SmithKline Beecham (parent company) but were imported directly from abroad and not purchased through the local distributor, SmithKline Beecham Research Limited (which later merged into Glaxo SmithKline).
• The medicines were identical in content to their Philippine-registered counterparts and were neither adulterated nor mislabeled; their classification as "counterfeit" under RA 8203 was based solely on the fact that they were imported without registration with the Bureau of Patents, Trademarks and Technology Transfer.
• The NBI filed a criminal complaint against Rodriguez for violation of Section 4 (in relation to Sections 3 and 5) of RA 8203, which prohibits the sale of counterfeit drugs defined to include "unregistered imported drug products."
• During preliminary investigation, Rodriguez challenged the constitutionality of the SLCD provisions, but the Provincial Prosecutor proceeded to approve the filing of charges on August 17, 2001.

• Rodriguez asserted that Sections 3(b)(3), 4, and 5 of RA 8203 (Special Law on Counterfeit Drugs) are unconstitutional for violating the equal protection clause of the Bill of Rights.
• He argued that the challenged provisions contravene Section 11, Article XIII of the Constitution, which mandates the State to make essential goods, health, and other social services available to all people at affordable cost.
• He further contended that the provisions violate Section 15, Article II, which establishes the State policy to protect and promote the right to health of the people.
• He sought the issuance of a writ of prohibition to enjoin the RTC and Provincial Prosecutor from further prosecuting him.

• Glaxo SmithKline invoked the presumption of constitutionality of the SLCD, arguing that the constitutional provisions cited by petitioner are not self-executing and cannot be used to oppress the property rights of legitimate manufacturers who register their products.
• Glaxo SmithKline maintained that the SLCD does not conflict with but rather accords with constitutional precepts favoring the people's right to health by ensuring genuine medicines.
• The Office of the Solicitor General characterized the issue as one of policy wisdom beyond judicial interference, invoked the presumption of constitutionality, and asserted that no clear breach of the Constitution was demonstrated by the SLCD.

• Procedural Issues: Whether the Supreme Court should issue a writ of prohibition to enjoin the criminal prosecution of the petitioner pending the resolution of the constitutional challenge.
• Substantive Issues:
  • Whether Sections 3(b)(3), 4, and 5 of RA 8203 violate the equal protection clause and the constitutional provisions on the right to health and affordable medicines.
  • Whether the subsequent enactment of RA 9502 effectively abrogates the conflicting provisions of RA 8203 regarding the criminalization of importing unregistered drugs.

• Procedural: The Court granted the petition for prohibition and issued a writ commanding respondents to desist from prosecuting Rodriguez, making the Temporary Restraining Order dated October 15, 2001 permanent.
• Substantive:
  • The Court declined to directly rule on the constitutional challenge because the issue was rendered moot by the passage of Republic Act No. 9502 (Universally Accessible Cheaper and Quality Medicines Act of 2008).
  • Section 7 of RA 9502 amends Section 72 of the Intellectual Property Code to grant private third parties the unqualified right to import patented drugs and medicines that have been introduced anywhere in the world.
  • The Implementing Rules of RA 9502 confirm that this right to import is available to any private third party.
  • There exists an irreconcilable conflict between RA 9502, which permits such importation, and RA 8203, which criminalizes it; under the principle "legis posteriors priores contrarias abrogant," the later law prevails and the prior law yields to the extent of the conflict.
  • The Court observed that had it reached the constitutional issue, the SLCD provisions would have been placed in serious doubt for being "heartless" and discriminatory, criminalizing even altruistic importation of life-saving medicines and denying the poor access to affordable healthcare.

• Presumption of Constitutionality — Statutes are presumed constitutional until clearly shown otherwise; the burden of proof lies with the challenger to demonstrate a clear and unequivocal breach of the Constitution.
• Mootness by Supervening Event — A constitutional challenge becomes moot when a subsequent legislative enactment resolves the controversy or changes the legal landscape, rendering judicial determination unnecessary.
• Implied Repeal (Legis posteriors priores contrarias abrogant) — A later statute that is irreconcilably inconsistent with a prior statute on the same subject matter abrogates the earlier law to the extent of the conflict; irreconcilability exists when the later law nullifies the purpose of the earlier act.
• Malum Prohibitum — Crimes defined by special laws that are malum prohibitum are punishable regardless of criminal intent or motive, as characterized by the Court regarding the SLCD provisions.

• "For a law that is intended to help save lives, the SLCD has revealed itself as a heartless, soulless legislative piece."
• "Legis posteriors priores contrarias abrogant."
• "The absurd results from this far-reaching ban extends to implications that deny the basic decencies of humanity."
• "It discriminates, at the expense of health, against poor Filipinos without means to travel abroad to purchase less expensive medicines in favor of their wealthier brethren able to do so."

• Ramirez v. Court of Appeals, G.R. No. 23984, January 24, 1974, 55 SCRA 261 — Cited for the principle that when a subsequent enactment covering a field coterminous with a prior statute cannot be given effect while the prior law remains operative due to irreconcilable conflict, the latest legislative expression prevails and the prior law yields.

• 1987 Constitution, Article II, Section 15 — Mandates State policy to protect and promote the right to health of the people and instill health consciousness.
• 1987 Constitution, Article XIII, Section 11 — Requires the State to make essential goods, health, and other social services available to all people at affordable cost.
• Republic Act No. 8203 (Special Law on Counterfeit Drugs), Sections 3(b)(3), 4, and 5 — Defined "unregistered imported drug products" as counterfeit drugs, prohibited their sale, and prescribed penalties therefor; the provisions challenged as unconstitutional.
• Republic Act No. 8293 (Intellectual Property Code), Section 72 — Limitations on patent rights, as amended by Section 7 of RA 9502 to allow parallel importation of drugs and medicines.
• Republic Act No. 9502 (Universally Accessible Cheaper and Quality Medicines Act of 2008), Section 7 — Amends Section 72 of the IP Code to expressly grant third persons, including private parties, the right to import patented drugs introduced anywhere in the world.
• Rule 9, Implementing Rules to Republic Act No. 9502 — Confirms that the right to import drugs and medicines under the limitation on patent rights is available to any private third party.